Kyowa Hakko Kirin and Reata Pharmaceuticals entered into a licensing agreement on bardoxolone methyl in Japan and other selected Asian markets.- Bardoxolone methyl is a small molecule compound currently being developed in Phase II clinical trials in the US by Reata Pharmaceuticals for the treatment of chronic kidney disease in diabetic patients. -

Kyowa Hakko Kirin Co., Ltd. (Kyowa Hakko Kirin) based in Tokyo, Japan and Reata Pharmaceuticals, Inc. (Reata) based in Irving, Texas, USA announced that they have entered into a licensing agreement that provides Kyowa Hakko Kirin with the exclusive right to develop and commercialize Reata’s lead compound, bardoxolone methyl, in Japan, China, Taiwan, Korea and Southeast Asian markets.

Under the terms of the agreement, Reata will receive an up-front payment of $35 million and $97 million in development milestones and also be entitled to receive up to $140 million in sales milestones as well as double-digit royalties from Kyowa Hakko Kirin sales in the licensed territories. Reata retains the rights to develop and commercialize bardoxolone methyl in all other territories not licensed to Kyowa Hakko Kirin.

Bardoxolone methyl activates the Nrf2 gene^*1, which controls the production of over 250 antioxidant and detoxification proteins. Activation of Nrf2 protects tissues by increasing cellular antioxidant content and suppressing inflammatory signaling pathways. It is known that chronic inflammation promotes type 2 diabetes and its complications, including cardiovascular disease and CKD.

In two Phase II trials conducted by Reata in the US, bardoxolone methyl significantly improved renal function in diabetic nephropathy patients (type 2 diabetic patients with CKD). More than 90% of patients in these studies experienced an increase in estimated glomerular filtration rate (eGFR)^*2, a marker of renal function, from baseline. Significant improvements were also seen in other markers of renal function, glycemic control, and cardiovascular disease.

Kyowa Hakko Kirin is focusing its efforts to create new medical values, with its core R&D target of oncology, nephrology and immunology fields. The partnership with Reata will enrich the product pipeline in the nephrology field, which provides new therapeutic options to patients and medical professionals and contributes to the treatment of renal disease.